The following data is part of a premarket notification filed by Lifescan Europe, A Division Of Cilag Gmbh with the FDA for Onetouch Via On-demand Insulin Delivery System.
Device ID | K163357 |
510k Number | K163357 |
Device Name: | OneTouch Via On-Demand Insulin Delivery System |
Classification | Pump, Infusion, Insulin Bolus |
Applicant | LifeScan Europe, A Division Of Cilag GmbH Gubelstrasse 34 Zug, CH Ch-6300 |
Contact | Kirsten Franco |
Correspondent | Kirsten Franco LifeScan Inc. 965 Chesterbrook Blvd Wayne, PA 19087 |
Product Code | OPP |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-30 |
Decision Date | 2017-06-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00373108000037 | K163357 | 000 |
00373108000020 | K163357 | 000 |
00373108000006 | K163357 | 000 |
00373108000013 | K163357 | 000 |